Clinical

Rosiglitazone usually safe for diabetic hemodialysis patients with hepatitis

Last Updated: 2007-01-10 14:44:22 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Rosiglitazone appears to be generally safe and effective in patients with diabetes and viral hepatitis who are also undergoing treatment with hemodialysis, physicians in Taiwan report. However, their findings also suggest that the drug may cause deterioration in cardiovascular reserve.

The conundrum of whether to use a thiazolidinedione in end-stage renal disease is related to their combination of likely benefits - effective targeting of insulin resistance, cardiovascular protection, and anti-inflammatory properties - versus the potential for fluid retention and hepatotoxicity, Dr. Kuan-Yu Hung and his associates explain in the January issue of Diabetes Care.

Dr. Hung, at the National Taiwan University Hospital in Taipei, and colleagues conducted a prospective study of safety issues associated with rosiglitazone use in 72 patients with type 2 diabetes, with or without viral hepatitis, while undergoing dialysis for at least a year.

Rosiglitazone was initiated at 2 - 4 mg/day, titrated up to a maximum 8 mg/day, while other preexisting antidiabetic agents were maintained. Mean follow-up was 15.4 months, and mean duration of hemodialysis was 28.2 months.

Benefits included significant reductions in fasting glucose from 142 to 102.8 mg/dL and of HbA1c from 8.6% to 7.1%, without any episodes of hypoglycemia. Serum triglycerides declined from 194 to 168 mg/dL.

Overall, C reactive protein levels remained unchanged, although the 37 patients on the highest dose of rosiglitazone did exhibit a significant decrease in the inflammatory marker.

Other positive signs were the lack of effect of rosiglitazone on levels of alanine aminotransferase or aspartate aminotransferase in the group as a whole or among the 12 patients with chronic hepatitis B or 13 with hepatitis C.

Dr. Hung's group was concerned that rosiglitazone was associated with significant increases in mean cardiothoracic ratio, dry weight, and interdialysis body weight, even though blood pressure remained stable. They therefore conclude that, despite generally encouraging findings, longer-term studies will be required to establish the drug's impact on cardiovascular reserve.

Diabetes Care 2007;30:3-7.